Trichomonas Vaginalis Repeat Infections Among HIV Negative Women

This study is currently recruiting participants.
Verified March 2014 by Tulane University Health Sciences Center
Sponsor:
Information provided by (Responsible Party):
Patricia Kissinger, Tulane University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT01832480
First received: April 4, 2013
Last updated: March 1, 2014
Last verified: March 2014

April 4, 2013
March 1, 2014
June 2013
December 2017   (final data collection date for primary outcome measure)
TV negative after treatment with either multi or single dose MTZ [ Time Frame: 1 month post treatment completion ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01832480 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Trichomonas Vaginalis Repeat Infections Among HIV Negative Women
Trichomonas Vaginalis Repeat Infections Among HIV Negative Women

The overall goal of this project is to determine the influence of patient treatment, host factors and partner treatment on repeat Trichomonas vaginalis (TV) infections among HIV-negative women

This study is a phase IV two-factorial (dosing and partner treatment) randomized clinical trial. HIV-negative women who test positive for TV at their routine gynecological exam at participating clinics will be referred to the nurse/study coordinator to screen for eligibility, provide a description of the study, and obtain written, informed consent (N=2883). Subjects will undergo an audio computer assisted self- interview (ACASI), and will self-collect a vaginal swab for Gram stain testing and be randomized into one of four arms based on 2 factors; dosing -- metronidazole (MTZ) 2 g single dose (CDC recommended treatment regimen) or MTZ 500 mg BID 7-day dose (CDC alternative treatment regimen); and partner treatment -- patient-delivered partner treatment (PDPT) or partner referral (PR). The four arms are MTZ single dose/PDPT, MTZ single dose/PR, MTZ 7d dose/PDPT, and MTZ 7d dose/PR. All enrolled women will be asked to return for a follow-up visit at one month after baseline (window 4-6 weeks).

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Vaginitis Trichomonal or Due to Trichomonas
  • Partner Communication
  • Drug: MTZ 250 mg BID
    MTZ 250 mg BID
    Other Name: Multi-dose
  • Drug: PDPT
    patient delivered partner treatment of MTZ
    Other Name: Patient delivered partner treatment
  • Drug: MTZ 2 g
    MTZ 2 g
    Other Name: Single dose MTZ
  • Other: Partner referral
    Partner Referral to seek treatment
    Other Name: Partner Referral
  • Experimental: MTZ 2 g and PDPT
    Single dose MTZ and Patient delivered partner treatment
    Interventions:
    • Drug: PDPT
    • Drug: MTZ 2 g
  • Active Comparator: MTZ 2 g and Partner referral
    Single dose MTZ and Partner referral
    Interventions:
    • Drug: MTZ 2 g
    • Other: Partner referral
  • Experimental: Metronidazole 250 mg BID and PDPT
    Multi dose MTZ and patient delivered partner treatment
    Interventions:
    • Drug: MTZ 250 mg BID
    • Drug: PDPT
  • Experimental: MTZ 250 mg BID and Partner referral
    Multi dose MTZ and partner referral
    Interventions:
    • Drug: MTZ 250 mg BID
    • Other: Partner referral

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2883
December 2017
December 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • female
  • English speaking
  • >= 18 years old (Crossroads and Delgado); >=19 years old (JCDH)

Exclusion Criteria:

  • HIV-infected
  • unable to provide informed consent
Female
18 Years and older
No
Contact: Patricia Kissinger, PhD kissing@tulane.edu
United States
 
NCT01832480
4042013
Yes
Patricia Kissinger, Tulane University Health Sciences Center
Tulane University Health Sciences Center
Not Provided
Principal Investigator: Patricia Kissinger, MD Tulane Univeristy
Tulane University Health Sciences Center
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP